U.S. patent number 11,123,509 [Application Number 15/594,381] was granted by the patent office on 2021-09-21 for respiratory treatment apparatus.
This patent grant is currently assigned to Provincial Health Services Authority. The grantee listed for this patent is PROVINCIAL HEALTH SERVICES AUTHORITY. Invention is credited to F. Robert Purdy.
United States Patent |
11,123,509 |
Purdy |
September 21, 2021 |
Respiratory treatment apparatus
Abstract
Disclosed is a respiratory treatment apparatus that may be
especially helpful for pediatric patients, though it may be useful
for patients of all ages. In one embodiment, the apparatus
comprises an endotracheal tube that is physically coupled to a
bronchial blocker in a non-concentric fashion. In another
embodiment, the apparatus comprises an endotracheal tube that is
physically coupled to a steering balloon apparatus. The
endotracheal tube, bronchial blocker, and/or steering balloon
apparatus may be non-unitary components that are attachable to one
another with one or more attachment structures, and once physically
coupled, may be put to use. The endotracheal tube and bronchial
blocker and steering balloon apparatus may be selected from a
plurality of endotracheal tubes and bronchial blockers and steering
balloon apparatus, to create an assembled apparatus that meets the
needs of the patient.
Inventors: |
Purdy; F. Robert (Vancouver,
CA) |
Applicant: |
Name |
City |
State |
Country |
Type |
PROVINCIAL HEALTH SERVICES AUTHORITY |
Vancouver |
N/A |
CA |
|
|
Assignee: |
Provincial Health Services
Authority (Vancouver, CA)
|
Family
ID: |
64095932 |
Appl.
No.: |
15/594,381 |
Filed: |
May 12, 2017 |
Prior Publication Data
|
|
|
|
Document
Identifier |
Publication Date |
|
US 20180326168 A1 |
Nov 15, 2018 |
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F
2/50 (20130101); A61M 16/0459 (20140204); A61M
16/0463 (20130101); A61M 16/0404 (20140204); A61M
16/044 (20130101) |
Current International
Class: |
A61M
16/04 (20060101); A61F 2/50 (20060101) |
References Cited
[Referenced By]
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Nov 2013 |
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WO |
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Other References
Templeton et al., "Bending the rules: a novel approach to placement
and retrospective experience with the 5 French Arndt endobronchial
blocker in children <2 years," Pediatric Anesthesia 26 (2016)
512-520. cited by applicant .
Pawar et al., "One lung ventilation in infants and children:
experience with Marraro double lumen tube," Pediatric Anesthesia
2005 15:204-208. cited by applicant .
Fitzgerald et al., "Techniques for single lung ventilation in
infants and children," ATOTW 322 (Oct. 23, 2015),
www.wfsahq.org/resources/anaesthesia-tutorial-of-the-week. cited by
applicant .
Wilson et al., "Anesthetic techniques to facilitate lung lavage for
pulmonary alveolar proteinosis in children--new airway techniques
and a review of the literature," Pediatric Anesthesia 25 (2015)
546-553. cited by applicant .
Golianu, et al., "Pediatric thoracic anesthesia," Curr Opin
Anaesthesiol. Feb. 2005;18(1):5-11. cited by applicant.
|
Primary Examiner: Luarca; Margaret M
Assistant Examiner: Heffner; Ned T
Attorney, Agent or Firm: Oyen Wiggs Green & Mutala
LLP
Claims
The invention claimed is:
1. An apparatus comprising: an endotracheal tube having a proximal
end and a distal end; and a bronchial blocker having a proximal end
and a distal end, the distal end of the bronchial blocker including
an inflatable element receivable within a bronchus of a lung, the
inflatable element inflatable to substantially occlude the bronchus
within which the inflatable element is received to prevent flow of
fluid into or out of the lung; wherein the endotracheal tube and
the bronchial blocker as non-unitary elements are detachably
physically coupled to one another by a first attachment structure
near the distal end of the endotracheal tube to form a single unit
wherein the bronchial blocker and the endotracheal tube are
side-by-side and non-concentric; and wherein the distal end of the
bronchial blocker extends beyond the distal end of the endotracheal
tube.
2. The apparatus of claim 1, wherein the bronchial blocker includes
an inflation tube; wherein the endotracheal tube comprises a right
side and a left side; wherein the endotracheal tube comprises the
first attachment structure disposed on the right side of the
endotracheal tube and a second attachment structure disposed on the
left side of the endotracheal tube; and wherein the first
attachment structure and the second attachment structure are sized
to receive the inflation tube of the bronchial blocker.
3. The apparatus of claim 2, wherein the first attachment structure
comprises a groove and the second attachment structure comprises a
groove.
4. The apparatus of claim 1, wherein the first attachment structure
comprises a bio-compatible adhesive.
5. The apparatus of claim 4, wherein the first attachment structure
comprises an adhesive strip, and wherein the adhesive strip
comprises the bio-compatible adhesive.
6. The apparatus of claim 1, wherein the endotracheal tube
comprises: a third inflatable element disposed near the distal end
of the endotracheal tube; and a third inflation tube in fluid
communication with the third inflatable element; wherein inflating
the third inflatable element deflects the inflatable element of the
bronchial blocker laterally relative to the distal end of the
endotracheal tube.
7. The apparatus of claim 6, further comprising: a bulb in fluid
communication with the third inflation tube and the third
inflatable element.
8. The apparatus of claim 1 wherein the bronchial blocker is
detachably physically coupled to the endotracheal tube to move
together longitudinally with the endotracheal tube.
9. The apparatus of claim 8 wherein the bronchial blocker comprises
an inflation tube coupling the inflatable element of the bronchial
blocker to the endotracheal tube, the inflatable element suspended
from the inflation tube such that the inflatable element is movable
laterally relative to the distal end of the endotracheal tube.
10. The apparatus of claim 1, wherein the endotracheal tube
comprises: a first inflatable element disposed near the distal end
of the endotracheal tube; and a first inflation tube in fluid
communication with the first inflatable element; wherein the first
inflatable element comprises a circumferential inflatable cuff.
11. The apparatus of claim 1, wherein the bronchial blocker
comprises: a second inflation tube in fluid communication with the
inflatable element of the bronchial blocker.
12. The apparatus of claim 1, wherein the endotracheal tube
comprises an endotracheal tube lumen having an internal diameter,
and wherein the internal diameter is in the range of 2.0 mm to 9.0
mm.
13. The apparatus of claim 1, wherein the bronchial blocker
includes an inflation tube, and wherein the inflation tube of the
bronchial blocker and the endotracheal tube are side-by-side.
14. The apparatus of claim 1 wherein the bronchial blocker is
detachably physically coupled to the endotracheal tube to rotate
with the endotracheal tube.
15. The apparatus of claim 1 wherein the endotracheal tube and the
bronchial blocker are detachably physically coupled to one another
by an additional attachment structure located near a midpoint
between the distal end and the proximal end of the endotracheal
tube.
16. A kit comprising: a plurality of endotracheal tubes of variant
sizes and configurations, each of the plurality of endotracheal
tubes having a proximal end and a distal end; and a plurality of
bronchial blockers of variant sizes and configurations, each of the
plurality of bronchial blockers having a proximal and a distal end,
the distal end of each of the plurality of bronchial blockers
including an inflatable element receivable within a bronchus of a
lung, the inflatable element inflatable to substantially occlude
the bronchus within which the inflatable element is received to
prevent flow of fluid into or out of the lung; wherein any of the
endotracheal tubes in the plurality of endotracheal tubes is
configured to be capable of physical coupling to any of the
bronchial blockers in the plurality of bronchial blockers, with an
attachment structure to form a single unit wherein when any
selected one of the endotracheal tubes is physically coupled to any
selected one of the bronchial blockers, the selected endotracheal
tube and the selected bronchial blocker are side-by-side and
non-concentric and the distal end of the selected bronchial blocker
extends beyond the distal end of the selected endotracheal
tube.
17. The kit of claim 16, wherein at least one of the endotracheal
tubes in the plurality of endotracheal tubes includes an
endotracheal tube lumen having a first internal diameter, and
another of the endotracheal tubes in the plurality of endotracheal
tubes includes an endotracheal tube lumen having a second internal
diameter.
18. The kit of claim 17, wherein the first internal diameter and
the second internal diameter are in a range of 2.0 mm to 9.0
mm.
19. The kit of claim 16, further comprising: a plurality of
steering balloon apparatus of variant sizes and configurations;
wherein any of the endotracheal tubes in the plurality of
endotracheal tubes is configured to be capable of physical coupling
to any of the steering balloon apparatus in the plurality of
steering balloon apparatus, with the attachment structure.
Description
FIELD
The present disclosure is directed to apparatus used for medical
treatment involving the respiratory system, and more particularly,
apparatus for occluding a part of the respiratory system or
isolating the respiratory system from other systems such as the
digestive system.
BACKGROUND
In a healthy patient, both lungs inflate and deflate together
during respiration. In cases of some pulmonary or thoracic
surgeries, it may be important to isolate a lung or mechanically
separate the lungs from working together. With "lung isolation"
and/or "one lung ventilation," one lung participates in
respiration, while the other lung may be deflated or rendered
inactive. Lung isolation and/or one lung ventilation may be used in
cases such as those in which one lung is healthy and the other is
not, or when surgery is required on one side of the chest, or in
numerous other situations.
To achieve lung isolation and/or one lung ventilation, a portion of
the respiratory system may be intentionally occluded by medical
apparatus. Typically an anatomical passage to a lung or a portion
of a lung may be blocked to prevent the flow of fluids (gases
and/or liquids). Such an occlusion may prevent substances such as
blood and secretions from moving from one lung to the other lung,
for example. It allows the blocked side to collapse or deflate and
improve access for surgery.
Lung isolation and/or one lung ventilation in pediatric patients
(most notably the very small patients: premature babies, neonates,
and infants) may present challenges that are not present in adult
human beings. Some of the challenges are due in part to the
comparatively small size of the anatomical structures of pediatric
patients, notably the trachea and the two major bronchi.
Also, it is not uncommon for newborns to have a congenital
malformation of the respiratory system called a Tracheoesophageal
Fistulas (or TEF). With a TEF, there may be a direct connection
between the trachea of the respiratory system and the esophagus of
the digestive system. TEFs are often associated with several other
congenital malformations, including cardiac defects. The connection
between the esophagus and trachea may allow stomach contents to
regurgitate into the trachea and lungs. When a baby having a TEF is
resuscitated or anesthetized, positive pressure ventilation may
severely inflate the stomach, potentially compromising ventilation
and potentially leading to life-threatening consequences.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a schematic view of an illustrative medical device in a
human respiratory system;
FIG. 2 is a schematic view of the illustrative medical device in
shown in FIG. 1, illustrating the constituent components
thereof;
FIG. 3A is a cross-sectional view of an illustrative endotracheal
tube and a tube of a bronchial blocker;
FIG. 3B is a cross-sectional view of the illustrative endotracheal
tube and the tube of the bronchial blocker depicted in FIG. 3A,
with the endotracheal tube physically coupled to the tube of the
bronchial blocker;
FIG. 3C is a cross-sectional view of another illustrative
endotracheal tube;
FIG. 3D is a schematic view of an illustrative kit comprising a
plurality of endotracheal tubes and a plurality of bronchial
blockers.
FIG. 4 is a flow diagram illustrating a method for preparation of a
medical apparatus;
FIG. 5 is a plan view of a distal end of an illustrative
endotracheal tube and tube of a bronchial blocker that have been
physically coupled; and
FIG. 6 is a schematic view of another illustrative medical device
used with the respiratory and digestive systems of a newborn
patient.
DETAILED DESCRIPTION
The present disclosure describes apparatus for medical treatment
involving the respiratory system. Such medical treatment may
include lung isolation and/or one lung ventilation, and procedures
to address physiological concerns or malformations such as TEFs.
The disclosure will be presented, at least in part, in the context
of use with pediatric patients, for whom the disclosed apparatus
may carry many potential advantages. It should be noted, however,
that the disclosed apparatus is not limited to use with pediatric
patients, and one potential advantage of this disclosure is that
the apparatus may be readily scaled or adapted for use with adult
patients. (The apparatus may be adapted for veterinary patients as
well, but this disclosure will focus upon human patients.) Also,
many of the potential advantages of the apparatus carry over for
patients of all ages. For example, the apparatus may be useful for
children and adults in emergency and intensive care settings, where
rapid lung isolation is required, such as in the case of a massive
pulmonary hemorrhage. Further potential benefits will be discussed
below.
FIG. 1 is an illustration of a portion of a human respiratory
system 100. For purposes of illustration, the portion of the human
respiratory system 100 may be that of an older pediatric patient
(rather than an infant or neonate) having anatomical passages
similar to but substantially smaller than comparable structures on
an adult.
The portion of the human respiratory system 100 includes a trachea
102, having cartilaginous rings 104. The trachea 102 serves as an
airway between the environment and the patient's lungs (not shown).
The airway of the trachea 102 branches at the carina into a right
mainstem bronchus 106 and a left mainstem bronchus 108. (By
convention, left and right are from the point of view of the
patient.) The right bronchus 106 enters the right lung (not shown)
and the left bronchus 108 enters the left lung (not shown). The
airways of the mainstem bronchi 106, 108 divide into smaller airway
passages called secondary bronchi (not shown) and the secondary
bronchi divide into tertiary bronchi (not shown). Occluding the
mainstem bronchus 106 or 108 of a lung will isolate all of the
airway passages of that lung, and the non-occluded bronchus 108 or
106 remains open, allowing ventilation through that bronchus.
In most patients, there are some anatomical differences between the
right side and the left side of the respiratory system. These
anatomical differences are not depicted in FIG. 1.
FIG. 1 depicts an illustrative apparatus 110, deployed to achieve
lung isolation and/or one lung ventilation. FIG. 2 is a schematic
diagram that shows the apparatus 110 in a manner that depicts the
components of the apparatus 110 for clarity; but the components are
not drawn to scale, and not all structures are depicted in both
FIG. 1 and FIG. 2.
The apparatus 110 includes an endotracheal tube 112 inserted into
the trachea 102. The endotracheal tube 112 generally serves the
purposes of establishing, maintaining and securing the airway, and
avoiding interference from anatomical structures such as the vocal
chords or epiglottis. The endotracheal tube has a proximal end 114
and a distal end 116. The distal end 116 is typically beveled and
may but need not include a "Murphy Eye" (not shown in FIG. 1). The
distal end 116 is inserted into the patient's trachea 102. The
endotracheal tube 112 includes an endotracheal tube lumen 118
through which some solids and fluids and medical instruments may
pass. In some surgical procedures, the endotracheal tube 112 forms
a passageway for introduction of medical apparatus, such as a
bronchial blocker (also called an endobronchial blocker), through
the endotracheal tube lumen 118 into the patient's respiratory
system 100. In FIG. 1, however, a bronchial blocker 120 is
introduced into the patient's respiratory system 100, but not by
way of passage through the endotracheal tube lumen 118.
The endotracheal tube 112 may be described in terms of its external
diameter, from one cross-sectional edge to another. The
endotracheal tube 112 may also be described in terms of its
internal diameter, basically the width of the endotracheal tube
lumen 118. Such dimensions are typically expressed as conventional
dimensions with some degree of tolerance, and not as exact
measurements.
The endotracheal tube 110 may include an inflatable element 122
(which may be denoted for convenience as a "first" inflatable
element 122), shown in the form of a circumferential inflatable
cuff (and an element of this kind is often referred to as a
"cuff"). For a very small patient, the cuff 122 may be considerably
smaller than is depicted in FIG. 1, and may, for some pediatric
patients, be omitted. (If the cuff is omitted, the endotracheal
tube is termed an "uncuffed" endotracheal tube.) In FIG. 1, the
cuff 122 is depicted in its inflated configuration, and in FIG. 2,
the cuff 122 is less than completely inflated. The endotracheal
tube 112 typically includes an inflation tube 124 having an
inflation lumen 126 (not shown in FIG. 1, and which may be denoted
for convenience as a "first" inflation tube 124 having a "first"
inflation lumen 126, distinct from the endotracheal tube 112 and
endotracheal tube lumen 118), to supply inflation to the cuff 122
or deflate the cuff 122. The first inflation tube 124 with the
first inflation lumen 126 is in fluid communication with the first
inflatable element 122. An inflation fluid such as air passing
through the first inflation lumen 126 will inflate or deflate the
cuff 122, depending upon whether the inflation fluid is moving
toward the proximal end 114 or the distal end 116.
The cuff 122 shown in FIG. 1 is disposed near to the distal end 116
of the endotracheal tube 112, though typically a small distance
away from the distal end 116. The distal end 116 of the
endotracheal tube 112 may extend into the trachea 102 beyond the
cuff 122. The cuff 122 shown in FIG. 1 is a low pressure-high
volume type cuff, which when inflated contacts a relatively large
surface area of the inner walls of the trachea 102. Further, the
cuff 122 shown in FIG. 1 is of a substantially uniform
cross-section, contacting the walls of the trachea 102
substantially equally in all directions. The cuff 122 shown is
illustrative, and the present disclosure is not limited to a
particular configuration of cuff, nor is the disclosure limited to
a cuff-like first inflatable element 122. When inflated, the cuff
122 makes a low-pressure seal with the trachea 102. This seal,
among other things, facilitates positive pressure ventilation and
protects the lungs from soiling from above, such as soiling with
oral secretions or stomach content. As will be discussed below, the
cuff 122 may serve additional functions as well, and may be
configured to perform some functions effectively.
FIG. 1 further shows a bronchial blocker 120. The bronchial blocker
120 includes a proximal end 128 and a distal end 130. The distal
end 130 of the bronchial blocker 120 may also be called the
"blocker tip." The distal end 130 of the bronchial blocker 120 is
deployed through the trachea 102 of the patient and into a mainstem
bronchus 106 or 108. FIG. 1 depicts the distal end 130 of the
bronchial blocker 120 descending into the right bronchus 106
(though descent into the left bronchus 108 may also be achieved, as
described below). The bronchial blocker 120 includes an inflatable
element 132 (which may be denoted for convenience as a "second"
inflatable element) 132 and an inflation tube 134 having an
inflation lumen 136 (which may be denoted for convenience as a
"second" inflation tube 134 having a "second" inflation lumen 136)
that is in fluid communication with the second inflatable element
132. An inflation fluid such as air passing through the second
inflation lumen 136 of the second inflation tube 134 toward the
distal end 130 will inflate the second inflatable element 132.
Similarly, an inflation fluid may move through the second inflation
lumen 136 of the second inflation tube 134 toward the proximal end
128, causing the second inflatable element 132 to deflate. The
second inflatable element 132 may conventionally be referred to as
a "balloon," which is disposed near to the distal end 130 of the
bronchial blocker 120. When inflated, the second inflatable element
132 occludes the bronchus 106 or 108 and thereby isolates the
lung.
As shown in FIG. 1, the bronchial blocker 120 is not deployed
through the endotracheal tube lumen 118. In other words, the second
inflation tube 134 (and its lumen 136) of the bronchial blocker 120
and the endotracheal tube 112 (and its lumen 118) are
non-concentric, that is, the former is not inside the latter.
Rather, the second inflation tube 134 of the bronchial blocker 120
and the endotracheal tube 112 are adjacent or side-by-side.
As depicted in FIG. 1, the endotracheal tube 112 includes another
inflatable element 138 (which may be denoted for convenience as a
"third" inflatable element 138) and an inflation tube 140 having an
inflation lumen 142 (which may be denoted for convenience as a
"third" inflation tube 140 having a "third" inflation lumen 142)
that serves to supply inflation to the third inflatable element 138
or deflate the third inflatable element 138. The third inflatable
element 138 is disposed near to the distal end 130 of the
endotracheal tube 112, and is generally nearer to the distal end
116 of the endotracheal tube 112 than is the first inflatable
element 122. The third inflatable element 138 may be referred to
conventionally as a "balloon," though the third inflatable element
138 may be structurally different from the second inflatable
element 132 (and may also be structurally different from the first
inflatable element 122). All inflatable elements 122, 132, and 138
may be inflated and/or deflated independently. The third inflatable
element 138 serves as a steering or directional or deflecting
element, that may urge the distal end 130 of the bronchial blocker
120 into the right mainstem bronchus 106 or the left mainstem
bronchus 108, as desired. In FIGS. 1 and 2, the third inflatable
element 138 is depicted as deflated. Further, in FIGS. 1 and 2, the
third inflatable element 138 is non-circumferential (not a
circumferential element surrounding most or all of the endotracheal
tube 112), dissimilar from the depicted first inflatable element
122; the third inflatable element 138 is also dissimilar from the
second inflatable element 132 which is an omnidirectional or
uniformly expanding balloon. Rather, the third inflatable element
138 may be small in comparison to the first inflatable element 122
and the second inflatable element 132, and may be configured to
expand directionally or laterally away from the third inflation
tube 140, and/or laterally away from the lumen 118 of the
endotracheal tube 112. In other words, the third inflatable element
138 may be configured to expand laterally away from a side of the
distal end 116 of the endotracheal tube 112.
In practice, the third inflatable element 138 may be thought of as
a "steering balloon," used to deflect or steer the blocker tip 130
to the lung that is to be occluded. As the distal end 130 of the
bronchial blocker 120 is inserted through the trachea 102, and the
distal end 130 is near to the right mainstem 106 bronchus and the
left mainstem bronchus 108, the third inflatable element 138 may be
inflated, thereby deflecting or biasing the blocker tip 130 toward
the desired bronchus. In FIG. 1, the third inflatable element 138
is shown deployed so as to bear against second inflation tube 134
of the bronchial blocker 120 (the third inflatable element 138
shown as now deflated), and thereby steer the blocker tip 130. The
third inflatable element 138 may be deployed in other ways as well,
and may steer the blocker tip 130 without necessarily bearing
against the bronchial blocker 120. The third inflatable element 138
would generally not be inflated to a degree to block any anatomical
passageway or to hold any apparatus in place; and once the desired
deflection is achieved and the distal end 130 of the bronchial
blocker 120 is entering the correct bronchus, the third inflatable
element 138 may be deflated. Such practice may enable fine control
over the manipulation of the blocker tip 130 toward the correct
site. Fine control over the manipulation of the blocker tip 130 may
also facilitate endotracheal intubation, notably during passage of
the apparatus 110 through the larynx of the patient during
endotracheal intubation.
In one variation, the third inflatable element 138 may be inflated
by use of a bulb or low-pressure balloon 144 near the proximal end
128 of the endotracheal tube 112. The third inflatable element 138
would be, by contrast, a high-pressure balloon. Thus, the third
inflatable element 138 would be biased to be deflated, while the
bulb 144 would tend to be expanded. The bulb 144 and third
inflatable element 138 would be in fluid communication with one
another via the third inflation lumen 142. The bulb 144, third
lumen 142, third inflation tube 140, and third inflatable element
138 could be a closed system. Such a system may be one example of a
steering balloon apparatus 146. Following insertion of the
bronchial blocker 120 through the trachea 102, the medical
professional (typically the anesthesiologist, who is usually
responsible for placement of apparatus into the patient's
respiratory system 100) may manually apply pressure to the bulb
144, thereby expelling air from the bulb 144 through the third
inflation lumen, thereby expanding the third inflatable element
138, thereby steering the blocker tip 130. After the blocker tip
130 is steered where it should go, the medical professional may
release pressure on the bulb 144, and the air in the third
inflatable element 138 would move through the lumen 142 to the
low-pressure bulb 144, thereby deflating the third inflatable
element 138.
Inflatable elements may be inflated or deflated by mechanical
elements 148 such as a syringe with a plunger such that, when the
syringe plunger is depressed, air is forced out of the syringe and
down a lumen and into the inflatable element. The inflatable
element may be maintained in an inflated condition by maintaining
the plunger in a depressed state. The inflatable element can be
deflated by withdrawal of the syringe plunger from the depressed
state. In the case of the third inflatable element 138, inflation
is expected to be for a comparative small interval of time, and the
third inflatable element 138 is ordinarily not maintained in an
inflated condition for a long time. Use of a bulb 144 such as
described above may therefore be a more efficient apparatus for
inflation and deflation. The concept includes other mechanical
elements 148 for inflation and deflation, however.
In practice, a typical use of the apparatus 110 would be as
follows. The endotracheal tube 112 and bronchial blocker 120 would
typically be "attachable" to one another. That is, the endotracheal
tube 112 and bronchial blocker 120 may be, prior to the patient's
surgical procedure, separate and non-unitary elements (that is, the
endotracheal tube 112 and bronchial blocker 120 need not be, but
may be, a unitary apparatus for which attachment is unnecessary).
The endotracheal tube 112 and bronchial blocker 120 would, however,
be sized and configured to be physically coupled to one another to
form the assembled apparatus 110. Further, the endotracheal tube
112 and bronchial blocker 120 may be configured to be capable of
physical coupling to one another with an attachment structure. Some
attachment structures are described or illustrated below. Generally
speaking, the endotracheal tube 112 and bronchial blocker 120 are
consistently oriented, so that the proximal end 114 of the
endotracheal tube 112 is near the proximal end 128 of the bronchial
blocker 120, and the distal end 116 of the endotracheal tube 112 is
near the distal end 130 of the bronchial blocker 120. If a steering
balloon is desired, then a third inflatable element 138, third tube
140 with third lumen 142, and bulb 144 may also be physically
coupled to the endotracheal tube 112, the bronchial blocker 120, or
both. In FIG. 1, the third inflatable element 138 is depicted as
physically coupled to endotracheal tube 112 near the distal end 116
of the endotracheal tube 112.
The assembled apparatus 110, comprising an endotracheal tube 112,
bronchial blocker 120 (with second inflatable element 132 and third
inflatable element 138 and associated apparatus) are simultaneously
introduced into the trachea 102. As will be discussed below, the
endotracheal tube 112 and bronchial blocker 120 may be physically
coupled so that they can be inserted into the patient as a single
unit. When the distal end 130 of the bronchial blocker 120 reaches
the mainstem bronchi 106 and 108, the third inflatable element 138
may be briefly inflated to steer or defect the distal end 130 of
the bronchial blocker 120 into the correct bronchus. Once the
distal end 130 is steered into the correct bronchus, the
endotracheal tube 112 and bronchial blocker 120 may be inserted
farther into the trachea 102. The distal end 116 of the
endotracheal tube 112 ordinarily would not be inserted into either
the right bronchus 106 or the left bronchus 108, but would remain
in the trachea 102. Medical instrumentation, such as a fiber optic
bronchoscope (not shown), may be used to check positioning of the
endotracheal tube 112 and bronchial blocker 120. Such
instrumentation may be introduced through a port 150 on the
proximal end 114 of the endotracheal tube 112. When positioning
seems to be satisfactory, the cuff 122 may be inflated to hold the
apparatus 110 in a fixed position with respect to the trachea 102,
and the second inflatable element 138 may be inflated to occlude
the correct mainstem bronchus 106 or 108.
FIG. 1 shows the bronchial blocker 120 steered to the right
bronchus 106. The bronchial blocker 120 may also be steered to the
left bronchus 108. As will be discussed in more detail below, the
bronchial blocker 120 may be physically coupled to the endotracheal
tube 112 in one fashion for positioning in the right bronchus 106,
and in a different fashion for positioning in the left bronchus
108. When the right bronchus 106 is to be occluded, the bronchial
blocker 120 may be physically coupled or attached to the right side
of the endotracheal tube 112; and when the left bronchus 108 is to
be blocked, the bronchial blocker 120 is physically coupled or
attached to the left side of the endotracheal tube 112.
The use of a steering balloon apparatus 146 is optional. In another
embodiment, the third inflatable element 138 and the third
inflation tube 140 having the third inflation lumen 142, and the
bulb 144 are omitted. The bronchial blocker 120 may be a
conventional bronchial blocker. In practice, the assembled
apparatus 110 comprising an endotracheal tube 112 and bronchial
blocker 120 are simultaneously introduced into the trachea 102.
When the distal end 130 of the bronchial blocker 120 reaches the
mainstem bronchi 106 and 108, the first inflatable element 122 may
be gently, but generally not fully, inflated. This maneuver may
serve to deflect the distal end 130 of the bronchial blocker 120
into the correct bronchus. (Some variations of cuffs may tend to
bias the distal end 130 of the bronchial blocker 120 to the left,
other variations to the right.) Once the distal element 130 is
steered into the correct bronchus, the first inflatable element 122
may be deflated, the endotracheal tube 112 and bronchial blocker
120 may be positioned, and the first inflatable element 122 may be
re-inflated, and the second inflatable element 132 may be inflated
to occlude the correct mainstem bronchus.
In a further variation, the bronchial blocker 120 is optional. In
this variation, the third inflation tube 140 may be physically
coupled to the endotracheal tube 112. In this variation, the third
inflatable element 138 of the steering balloon apparatus 146 may be
used to steer apparatus other than a bronchial blocker. For
purposes of illustration, a catheter (or other medical instrument,
such as, but not limited to, a flexible biopsy forceps, a grasping
forceps or basket for foreign bodies, a cautery cable, or a laser)
may be steered to a correct lung with the assistance of the third
inflatable element 138. A catheter directed into the respiratory
system 100 through the endotracheal tube 112 may have, for example,
a wire (or thread or suture; the word "wire" will be used to
encompass all variations of thin, elongated, generally flexible or
directionally changeable elements) attached to the catheter tip.
When placed in tension, the wire may tend to deflect the tip of the
catheter. The deflection may move the catheter tip medially (that
is, bow the catheter so that the tip is directed toward the body
midline), but the desire may be to move the body of the catheter
laterally (away from the midline). In such a case, the third
inflatable element 138 may be inflated to steer the catheter
laterally, while the catheter tip may be pointed in another
direction. In other words, instrument steering may be accomplished
with the third inflatable element 138 alone or acting in concert
with another steering element. In addition to manipulating the
wire, the direction in which the catheter tip is pointing may also
be steered by twisting or rotating the endotracheal tube 112.
Steering with multiple steering elements may support fine control
and precise positioning of the instrument.
Fine control and positioning may be very useful when dealing with a
TEF. On occasion, placement of a wire, catheter, balloon catheter
(which may serve as a blocker), or other instrument through the
trachea and into the fistula may be required to facilitate
anesthesia, to protect the lungs from soiling, and to aid the
surgeons in identifying the fistula and surgically correcting it.
Placement of this wire, catheter or balloon catheter can be
challenging. Use of one or more steering techniques and apparatus,
as described above and below, may advantageous assist in steering
an instrument (such as a bronchial blocker, wire, catheter or
balloon catheter) towards the TEF. This will be discussed in more
detail below.
In a further variation, a steering balloon apparatus 146 and
another piece of apparatus or instrument may be physically coupled
to the endotracheal tube 112. For example, the catheter described
in the previous paragraph (or another kind of instrument) may be
physically coupled to the endotracheal tube 112 (instead of going
through the endotracheal tube 112). The wire may be inside the
endotracheal tube 112, or outside the endotracheal tube 112, or
partway inside and outside (e.g., passing through a "Murphy Eye"
near the distal end 116 of the endotracheal tube 112). In this
variation, the wire and the third inflatable element 138 may
cooperate to steer the catheter tip.
It is also contemplated that the bronchial blocker 120 (or other
instrument) may be steered by multiple steering elements as well,
including applying tension to a wire (not shown), rotating the
endotracheal tube 112, deflecting with the inflatable element 138,
and inflating or deflating the cuff 122.
In a typical implementation involving an endotracheal tube 112 and
bronchial blocker 120, the endotracheal tube 112 and bronchial
blocker 120 are physically coupled to one another so that they are
inserted into the patient as a single unit. That is, it is
unnecessary to insert the endotracheal tube 112, and insert the
bronchial blocker 120 separately. Components are "physically
coupled" when they are attached or connected or joined to one
another, in any fashion, whether releasably or substantially
permanently, so that physical activity of one component generally
affects the other. The physical attachment or coupling may be
direct or by way of one or more intermediate elements. Physical
coupling does not require attachment along a full length of a
device or at any set number of attachment sites.
The endotracheal tube 112 and bronchial blocker 120 (and/or wire,
and/or catheter, and/or any other instrument) may be physically
coupled to one another in a number of ways, such as the following.
First: the bronchial blocker 120 may be fixed by a bio-compatible
adhesive (such as a glue) to a side of the endotracheal tube 112.
The adhesive may be applied at any time. Second: the endotracheal
tube 112 may be constructed to include a small groove or slot down
the side of the endotracheal tube 112. This small groove would be
sized to receive the bronchial blocker 120 (or any part thereof,
such as second inflation tube 134, or any other instrument). The
fit may be sufficiently snug that there would be a friction fit (no
adhesive necessary) so that the second inflation tube 134 would not
readily disengage from the groove on the side of the endotracheal
tube 112. Third: the small groove may include an adhesive, such as
a self-adhesive strip, such that the bronchial blocker 120 (or any
part thereof, or any other instrument) would be held in the groove
in part by adhesion. The adhesive strip may be protected by a
backing that can be peeled away to expose a bio-compatible
adhesive. Apart from a groove, the endotracheal tube 112 and/or the
bronchial blocker 120 (or any part thereof, or any other
instrument) may include other physical features (such as flat
surfaces or visible guidelines) to aid in adhesion. Fourth: a
self-adhesive strip may be in place down the side of the
endotracheal tube 112, without a groove or other physical feature.
The bronchial blocker 120 (or any part thereof, or any other
instrument) blocker 120 would attach to the endotracheal tube 112
by adhesion. Fifth: small structures and/or mechanical fasteners
may be deployed down a side of the endotracheal tube 112 and/or the
bronchial blocker 120 (or any part thereof, or any other
instrument) that can mechanically fasten the components or
instruments to the endotracheal tube 112. An example of such
structures and/or fasteners may be small clips on a side of the
endotracheal tube 112, into which the components or instruments may
be pressed. Other mechanical fasteners, such as snaps, catches,
loops, and hooks, are also contemplated. Sixth: the endotracheal
tube 112 and the bronchial blocker 120 (or any part thereof, or any
other instrument) may be constructed as a unitary structure, rather
than as separate structures to be joined. In this way, a wall of
the endotracheal tube 112 may serve also as the second tube 134,
for example, and may accommodate the second lumen 136. This list of
ways to physically couple the endotracheal tube 112 and bronchial
blocker 120 is not an exclusive list, and any combination of ways
may be employed.
The structures by which the endotracheal tube 112 and bronchial
blocker 120 may be physically coupled to one and another
(especially the first five examples, and other similar structures)
may be individually or collectively described as "attachment
structures." Such attachment structures may be a component of the
endotracheal tube 112 (such as one or more grooves or clefts), or
of the bronchial blocker 120 (such as a single adhesive strip), or
both (such as cooperative structures on both devices), or neither
(such as a separate adhesive that is applied to physically couple
the endotracheal tube 112 and the bronchial blocker 120).
It has been discovered that physically coupling the endotracheal
tube 112 and bronchial blocker 120 to one another need not
adversely affect the operation of the first inflatable element 122.
The second inflation tube 134 of the bronchial blocker 120 has been
found not to significantly affect the seal created when a cuff 122
is inflated. Although the first inflatable element 122 may include
one or more structures (such as a groove) to accommodate the second
inflation tube 134, experience has indicated that such
accommodating structures may be unnecessary. Also, experience has
indicated that inflation of a low-pressure first inflatable element
122 does not significantly affect the operation of the bronchial
blocker 120 or the capability of inflating or deflating the second
inflatable element 132.
It may be noted that the attachment structures may be disposed on
multiple places on the endotracheal tube 112. Further, some
attachment structures may be used, and some may be unused.
Illustrations of this concept are shown in FIGS. 3A, 3B, and 3C. By
way of example, an endotracheal tube 112, shown in cross-section,
may have a first groove 152 disposed on one side, and a second
groove 154 disposed on an opposite side. The first groove 152 and
the second groove 154 are sized to receive the second inflation
tube 134 that is a component of the bronchial blocker 120 (or other
instrument). The second tube 134 of the bronchial blocker 120 may
be physically coupled to the endotracheal tube 112 using either
groove 152 or 154. In FIG. 3B, the second tube 134 is physically
coupled in the second groove 154, and the first groove 152 is
unused. The selection of first groove 152 or second groove 154 may
bias the bronchial blocker 120 to tend toward the right bronchus
106 or the left bronchus 108. Such biasing may assist in steering
the blocker tip 130 to the correct bronchus. The grooves need not
be disposed as shown in FIGS. 3A and 3B, and there need not be any
particular number of grooves. FIG. 3C illustrates one possible
variation, with a set of two first grooves 152A and 152B disposed
on one side, and a set of two second grooves 154A and 154B disposed
on the opposite side. As an example, one groove on a side may
accommodate a bronchial blocker 120, and the other groove on the
same side may accommodate a steering balloon apparatus 146.
In the above list, many of the techniques (the first five examples)
support physically coupling the attachable endotracheal tube 112
and attachable bronchial blocker 120 shortly before actual use.
Consequently, an endotracheal tube 112 may be selected, sized
and/or configured for the needs of the patient, and a bronchial
blocker 120 may be selected, according to the patient's needs, and
the selected endotracheal tube 112 and selected bronchial blocker
120 may be physically coupled together. Also, selection of which
side of the endotracheal tube 112 for physical coupling of the
bronchial blocker 120 may support ready assembly of an apparatus
110 most useful for the patient, according to factors such as which
lung is the correct lung to be occluded, or the patient's size.
Physical coupling may support customization to a variety of
patients in other ways as well. Such physical coupling may take
only a matter of seconds or minutes to accomplish. The endotracheal
tube 112, or the bronchial blocker 120, or steering balloon
apparatus 146, or all three, may include physical features such as
markings that may assist the person physically coupling the
components to physically couple them in a desirable way (such as
physically coupling them so that the blocker tip 130 extends a
desired length beyond the distal end 116 of the endotracheal tube
112), which may make physical coupling proceed more quickly. As a
further consideration, the technique for physically coupling the
components may be different depending upon the age or size of the
patient. For a very small patient, the third technique (groove plus
adhesive) may be the most practical, but for a larger patient, a
different technique may be more practical.
The apparatus as described may be readily sized for pediatric
patients of a range of ages, as well as adult patients. The size
range of the endotracheal tube 112 may be from 2.0 to 9.0 mm
internal diameter (that is, the size range may be small for
premature babies and larger for adults ranging in size from 500
grams up to 300 kg or more for adults). Physically coupling the
endotracheal tube 112 and bronchial blocker 120 need not markedly
change either the external diameter or the internal diameter of the
endotracheal tube 112. Once the endotracheal tube 112 and bronchial
blocker 120 are physically coupled, the apparatus may be inserted
into the trachea 102. The bronchial blocker 120 may be quickly,
easily, precisely and safely positioned into the right bronchus 106
or the left bronchus 108, under direct vision such as by viewing
through a fiber optic bronchoscope. In some cases, medical
providers may find that correct positioning can be accomplished
without direct vision. The blocker tip 130 may be steered to the
correct bronchus using, for example, one or more techniques or
apparatus described above. The position of the bronchial blocker
120 is fixed and secured with respect to the endotracheal tube 112,
in that the bronchial blocker 120 is physically coupled to the
endotracheal tube 112. The security of the positioning of the
endotracheal tube 112 in the trachea 102 is improved once the
second inflatable element 132 is inflated in position. In the event
that the bronchial blocker 120 becomes dislodged at some point (due
to positioning of the patient, for example, or during surgery) the
inflatable elements 122 and 132 may be readily deflated, and the
apparatus 110 correctly re-positioned, and the inflatable elements
122 and 132 readily re-inflated.
Materials used to construct the apparatus may be conventional.
Tubes may be formed from, for example, polyvinyl chloride or
natural or synthetic rubber, or rubber-like materials. The tubes
may include additional structural features such as wire
reinforcement or radio opaque materials.
The concept can be embodied as a "kit," that is, as a collection of
components that can be assembled to the needs of a particular
patient. An apparatus 110 may be assembled quickly for a patient
from such a kit, taking into account factors such as the patient's
size and the lung that needs to be blocked (or other need, such as
addressing a TEF). FIG. 3D is a schematic view of a kit 1000
according to an example embodiment. Kit 1000 may include one or
more endotracheal tubes 112A, 112B, . . . , 112N of different sizes
or configurations, and one or more bronchial blockers 120A, 120B, .
. . , 120N of different sizes or configurations. Kit 1000 may
include one or more steering balloon apparatus of different sizes
or configurations. In a variation, some of the endotracheal tubes
112A, 112B, . . . , 112N may include the apparatus associated with
the steering balloon apparatus (e.g., with the endotracheal tube
and steering balloon apparatus already physically coupled), and
some may not. In another variation, some of the bronchial blockers
120A, 120B, . . . , 120N may include the apparatus associated with
the steering balloon apparatus, and some may not. By selection of
components of desired sizes and configurations, and by physically
coupling the components together, an apparatus best suited for the
patient (e.g., whether large or small, blocking the right side or
the left) may be readily selected, assembled and employed.
FIG. 4 illustrates an assembly process (156) for use with such a
kit. From a plurality of endotracheal tubes of variant sizes and
configurations, a particular endotracheal tube is selected (158).
From a plurality of bronchial blockers, a particular bronchial
blocker is selected (160). The selection of endotracheal tube and
bronchial blocker may depend upon, for example, the age of the
patient, the size of the patient, the medical objective to be
achieved (such as lung isolation), which bronchus is to be
occluded, the capability of the selected endotracheal tube and the
selected bronchial blocker to work together, and so on. The
bronchial blocker may be selected (160) before the endotracheal
tube is selected (158). Once the endotracheal tube and the
bronchial blocker are selected, the selected endotracheal tube may
be physically coupled to the selected bronchial blocker (162). The
endotracheal tubes and the bronchial blockers may be configured to
be capable of physical coupling to one another with an attachment
structure, such as grooves or adhesive. In an illustrative kit,
many (not all) of the endotracheal tubes in the plurality of
endotracheal tubes may be capable of physical coupling to many (if
not to all) of the bronchial blockers in the plurality of bronchial
blockers, as these components are generally configured to be
capable of physical coupling to one another with one or more
attachment structures. Once physical coupling is performed, the
assembled apparatus may be put to use.
Assembly may be performed by the anesthesiologist, for example, or
one operating under the direction of the anesthesiologist. A
typical usage of the assembled apparatus for lung isolation may be
a follows: the patient is anesthetized; the patient is intubated;
the patient is stabilized and the position of the endotracheal tube
is confirmed; a fiber optic bronchoscope is inserted into the
endotracheal tube; the tip of the bronchial blocker is steered to
the correct bronchus using one or more of the techniques described
above; the blocker is inflated and its placement confirmed; the
endotracheal tube is secured to the patient; the patient is
positioned; the position of the blocker is re-checked; and the
surgery proceeds. Numerous other scenarios are possible and are
contemplated, but in this typical scenario, many benefits of the
assembled apparatus may be realized in the ease of steering, the
time used to place the blocker, and the readiness with which the
assembled apparatus can be checked and re-positioned if
desired.
FIG. 5 shows a portion of an illustrative medical apparatus 164.
This apparatus 164 is sized for a neonate or an infant (aged from
day of birth to six months of age). Further, this apparatus was
constructed and was used for testing and evaluation of the
effectiveness and prospective advantages of some of the subject
matter claimed below.
A distal end 166 of an endotracheal tube 168 is depicted, along
with a distal end 170 of a bronchial blocker 172. The entirely of
the apparatus 164 is not shown in FIG. 5.
The endotracheal tube 168 includes a cuff-like first inflatable
element 174, shown in FIG. 5 as deflated. The first inflatable
element 174 is optional; for very small patients, such as premature
babies, a cuff (or other inflatable element) may be omitted. The
smallest conventional cuffed endotracheal tube may have an internal
diameter of about 3.0 mm, which may be too large for a premature
baby. For very small premature babies, an uncuffed 2.0 mm or 2.5 mm
diameter endotracheal tube may be used. For inclusion in a kit as
described above, endotracheal tubes may be available in 2.0 and/or
2.5 mm sizes, among others. Such small tubes may also be available
in cuffed and uncuffed varieties.
In FIG. 5, the first inflatable element 174 may be inflated and
deflated by way of a first inflation lumen in a first inflation
tube (not explicitly shown), included with the endotracheal tube
168. The bronchial blocker 172 includes a balloon-type second
inflatable element 176, shown in FIG. 5 as deflated. The second
inflatable element 176 is inflated and deflated by way of a second
inflation lumen in a second inflation tube 178.
The endotracheal tube 168 is physically coupled to the bronchial
blocker 172, such that the apparatus 164 can be inserted into the
patient as a single unit. Sliding the endotracheal tube 168 into
the patient's trachea also slides the bronchial blocker 172, and
vice versa. In the apparatus 164, the endotracheal tube 168 is
physically coupled to the bronchial blocker 172 by a bio-compatible
adhesive (not explicitly shown), which operates as an attachment
structure. The endotracheal tube 168 and the bronchial blocker 172,
particularly the second inflation lumen in a second inflation tube
178, are physically coupled side-by-side. The second inflation tube
178 of the bronchial blocker 172 is not inside the lumen 180 of the
endotracheal tube 168; in other words, the tubes are
non-concentric, and the second inflation tube 178 is side-by-side
with the endotracheal tube 168.
The embodiment of the apparatus 164 omits a third inflatable
element that may be used to steer the distal end 170 of the
bronchial blocker 172. It has been indicated by experimentation
that the distal end 170 of the bronchial blocker 172 may be steered
into the correct bronchus of a very young patient without a third
inflatable element. When the apparatus 164 is introduced into the
trachea of a very young patient, the first inflatable element 174
and the second inflatable element 176 are deflated. The
endotracheal tube 168 and the bronchial blocker 172 are physically
coupled side-by-side, which may serve to bias the distal end 170 of
the bronchial blocker 164 in a desired direction. When inserted
into the trachea, the distal end 170 of the bronchial blocker 164
may tend toward the left mainstem bronchus of the patient, for
example. If the left bronchus is to be occluded, such biasing may
be helpful in steering the distal end 170 where it ought to go. If
additional steering may be helpful, the first inflatable element
174 may be gently, but generally not fully, inflated when the
distal end 170 of the bronchial blocker 172 reaches the mainstem
bronchi. Such gentle inflation avoids holding the endotracheal tube
168 in place in the trachea. If the distal end 170 of the bronchial
blocker 172 is biased to the left, for example, inflation of the
first inflatable element 174 may urge the distal end 170 of the
bronchial blocker 172 further to the left, and into the correct
bronchus. The first inflatable element 174 may be deflated, the
endotracheal tube 168 and bronchial blocker 172 may be positioned,
the first inflatable element 174 may be re-inflated, and the second
inflatable element 176 may be inflated to occlude the correct
mainstem bronchus.
FIG. 6 shows a portion of an illustrative medical apparatus 182 in
an illustrative use with part of the respiratory and digestive
systems 184 of a neonate, that is, a newborn patient. The patient
is depicted as having a TEF 186, in which an opening has formed
between the trachea 188 and a segment of esophagus 190 leading to
the stomach (not shown in FIG. 6). The patient is further depicted
as having proximal esophageal atresia, in which the upper or
proximal end of the esophagus 192 terminates and does not connect
with the lower esophagus 190. There are many variations of
esophageal atresia (Gross of Boston, for example, identifies five
classifications); FIG. 6 depicts one of those variations, but the
apparatus and techniques may be applied to other variations as
well, as well as to other variations of fistulas. It may also be
noted that the trachea 188 and upper esophagus 190 are depicted in
FIG. 6 as separated from one another side-by-side; in an actual
patient, these structures may be physically closer to each other
and one may be behind the other.
The apparatus 182 includes an endotracheal tube 194, of which the
distal end 196 is shown in FIG. 6. The endotracheal tube 194 shown
in FIG. 6 need not have the same inner diameter as the endotracheal
tube 112 shown in FIG. 1 (and may have an inner diameter smaller
than the endotracheal tube 112 shown in FIG. 1); and the trachea
188 of the neonate may be considerably smaller than the trachea 102
shown in FIG. 1. The endotracheal tube 194 is uncuffed, that is,
the endotracheal tube 194 lacks an inflatable element comparable to
cuff 122 shown in FIG. 1.
A balloon catheter 198 (similar in some respects to the bronchial
blocker 120 shown in FIG. 1, but smaller and possibly having
structural differences that are not pertinent here) has been
physically coupled to the endotracheal tube 194. As shown in FIG.
6, the distal end 200 of the balloon catheter 198 has been directed
into the TEF 186, and the balloon 202 of the balloon catheter 198
has been inflated through a catheter tube 204. The inflated balloon
202 is blocking the fistula 186. This blocking of the passage to
the stomach may serve to prevent inflation of the stomach when
applying positive pressure ventilation to the lungs during surgery;
the blocking may also serve to prevent any passage of any substance
from the digestive system to the respiratory system, or vice versa.
Surgery may be performed shortly after birth to close the fistula
186 and repair the esophagus.
Blocking the fistula 186 can be a delicate procedure, and moving
the distal end 200 of the balloon catheter 198 into the TEF 186 can
be challenging. As depicted in FIG. 6, the lower end of the
esophagus 190 branches laterally away from the trachea 188 in this
patient. A steering balloon 206, inflated through a tube 208, is
depicted in FIG. 6 as directing or deflecting the distal end 200 of
the balloon catheter 198 into the TEF 186. The steering balloon 206
and/or tube 208 may be physically coupled to the endotracheal tube
194 by an attachment structure such as those described previously.
The steering balloon 206 can deflect the distal end 200 of the
balloon catheter 198 laterally, thereby supporting ready
introduction of the distal end 200 of the balloon catheter 198 into
the TEF 186. Although FIG. 6 depicts the catheter balloon 202 and
the steering balloon 206 inflated at the same time, it may also be
decided to deflate the steering balloon 206 before inflating the
catheter balloon 202; the balloons 202 and 206 are generally
independently inflatable elements.
As already mentioned, inflation and deflation of the steering
balloon 206 may be performed in concert with one or more other
steering techniques or apparatus, which may assist with directing
the balloon catheter 198 to a desired position.
As noted above, the apparatus and techniques may be applied to
different variations of esophageal atresias and fistulas. The
steering balloon 206 may be used to steer apparatus other than a
balloon catheter 198. For example, there may be a situation in
which it may be desired to introduce a wire through a fistula into
the patient's esophagus. The steering balloon 206 physically
coupled to the endothracheal tube 194 may be inflated to direct a
distal end of the wire through the fistula into the esophagus. The
steered apparatus may be, but need not be, physically coupled to
the endotracheal tube 194.
The disclosed apparatus and techniques for assembly and use thereof
may realize one or more potential advantages, many of which were
discovered or verified by clinical testing. Some of the potential
benefits or differences have been mentioned already. The disclosed
apparatus and techniques have been found by experimentation to
produce effects distinct from other apparatus and techniques.
For example, in patients less than six years of age, some medical
providers have accomplished lung isolation by placing an
endotracheal tube, and separately placing an bronchial blocker. The
separate placement of the bronchial blocker, if deployed through
the lumen of the endotracheal tube, is often time consuming and
requires significant dexterity and expertise. When the blocker tip
emerges from the distal end of the endotracheal tube, it may be
challenging to steer the blocker tip to the correct bronchus.
Further, it has been observed that if the bronchial blocker is
dislodged during positioning or surgery, re-positioning the
bronchial blocker may be difficult and time-consuming, possibly
delaying surgery and placing the patient at risk of complete airway
obstruction. Some pediatric anesthesiologists may place the blocker
"blind" (without direct vision such as with the use of a fiber
optic bronchoscope), and check positioning after placement. "Blind"
placement may simplify insertion, but it may also carry a risk of a
need for re-positioning.
It has been discovered by experimentation that the disclosed
apparatus 110 (and 164 and 182) can be placed more quickly and
readily, especially in a pediatric patient. The physical coupling
of components supports placement of the endotracheal tube 112 (and
168) and the bronchial blocker 120 (and 172) at about the same
time. Various physical features support steering the bronchial
blocker 120 (and 172) to the correct bronchus, possibly without
need for direct vision. Further, if the bronchial blocker 120 (and
172) is dislodged during positioning or surgery, re-positioning is
less difficult and time-consuming.
Due to the ease of insertion and rapidity of securing the bronchial
blocker 120 (and 172) in the correct bronchus, there is reduced
incidence of desaturation and hypoxic events, especially in infants
and neonates. Thus the airway can be secured after induction of
anesthesia, the patient ventilated and optimized, and then the
bronchial blocker 120 (and 172) advanced into the bronchus in a
controlled and stable setting.
A further potential advantage may be ready and rapid customization
of device sizes and features. Customization may be especially
advantageous for pediatric patients, in that components of
appropriate size may be selected, and may be assembled to make
proper placement easier. Once an endotracheal tube and the
bronchial blocker (for example) are selected, they can quickly and
readily be physically coupled together in a manner that may be
advantageous to the patient, such as by biasing the device to the
right or left bronchus. Many commercially available devices are
left-biased, and fewer are right-biased. The concept described
herein can help avoid the situation in which there is a shortage of
right-biased devices, because some embodiments support left- and
right-biasing on short notice.
Once the endotracheal tube and the bronchial blocker are physically
connected, the assembled apparatus may be easily and rapidly
inserted.
Customization enables not only the use of smaller components, but
also the use of larger ones. An endotracheal may be selected, for
example, that has a lumen with a larger internal diameter than may
be presently available in double-lumen tubes. Selecting a tube with
a larger lumen may be an advantage when, for example, there are
increased risks of the lumen becoming obstructed with secretions or
blood clots, or use of a larger fiber optic bronchoscope is
indicated, or more room for suction is indicated, or having less
resistance during ventilation is indicated. Further, an
endotracheal tube may be selected for positioning and/or
manipulating other diagnostic and therapeutic medical devices, such
as (but not limited to) flexible biopsy forceps, flexible cautery
cable, lasers, catheters, suction catheters, brushes, and other
medical instruments. An endotracheal tube may be selected based
upon a combination of factors as well as the size of the patient.
For example, an endotracheal tube may be selected to accommodate a
flexible basket and grasping forceps for removal of foreign bodies
in the airway; airway foreign bodies being an unfortunately common
medical problem in small children.
The embodiments described above are intended to be examples only.
Alterations, modifications and variations can be effected to the
particular embodiments without departing from the scope of the
concept, which is defined by the claims appended hereto.
* * * * *
References